FDA Releases Draft FSMA Guidance Amid Government Shutdown

Prior to the government shutdown, the Food and Drug Administration prepared and released a draft guidance document for hazard analysis and risk based preventive controls. FDA posted the document to the Federal Register for publication tomorrow. Comments will be accepted until July 23.

According to the Center for Veterinary Medicine update, the document covers five chapters:

  • food safety plan requirements;
  • recommendations for conducting a hazard analysis;
  • hazards associated with the manufacturing, processing, packing and holding of animal food;
  • examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
  • preventive control management components.

Appendix E lists animal food ingredients with specific references to different hazards. At first glance, this document seems to take the same approach of the human food draft guidance. Future chapters still have not been released for human food.

FDA stated that the guidance is designed to cover the entire spectrum of facilities subject to the animal food preventive controls requirements, and, therefore, not all of its content will be applicable to all facilities. FDA also said it intends to publish additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. As an example, FDA noted that a future guidance document will provide in-depth guidance on the supply-chain program preventive control.

Compliance Dates

Businesses that are not classified as “small” or “very small” businesses under the rule were required to comply with the animal food preventive control provisions on Sept. 18, 2017. “Small” businesses need to comply by no later than Sept. 17, 2018, and “very small” businesses need to comply with limited provisions by Sept. 17, 2019.